MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2D HELICAL - 35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 82885

Device Problems Entrapment of Device (1212); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and functional inspection revealed that a catheter and coil were returned for this complaint.The coil was stuck inside the catheter.It was necessary to cut the catheter in order to release the coil.The main coil was found stretched and kinked.No more damages were found in the device.During the product analysis the investigator was unable to remove the coil from the catheter due to the stretched and kinked.The investigator cut off the catheter and successfully removed the coil.A microscopic and dimensional inspection revealed that the proximal zap tip and distal tip of the main coil was within its specification aside from the fiber bundles which was missing due to the coil stretching.

Event Description

Reportable based on device analysis completed on 26mar2020.It was reported that the coil got stuck in the catheter.The target lesion was located in the portal vein.A 7mmx40mm 2d helical - 35 embolic coil was selected for use.During procedure, it was noted that the coil got stuck inside the delivery catheter.The device was removed as a unit and another of the same device was used to complete the procedure.No patient complications were reported and patient status was good.However, device analysis revealed missing fiber bundles.

• Brand Name: 2D HELICAL - 35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9913755
• MDR Text Key: 186098872
• Report Number: 2134265-2020-04202
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729158851
• UDI-Public: 08714729158851
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 82885
• Device Catalogue Number: 82885
• Device Lot Number: 0022119321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1